OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a novel endovascular graft for elective treatment of infrarenal abdominal aortic aneurysm. The device is a modular bifurcated system with nitinol/expanded polytetrafluoroethylene components and a smaller profile than currently approved devices. METHODS: In a multicenter, concurrent controlled phase II trial, 334 patients underwent treatment with the Excluder bifurcated endoprosthesis (test, n = 235; W. L. Gore & Associates, Inc, Sunnyvale, Calif) or with standard open repair (control, n = 99). Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 2 years were analyzed with univariable and multivariable statistics. RESULTS: Patients in the test group had less blood loss (310 +/- 19 mL versus 1590 +/- 124 mL; P <.0001), fewer homologous transfusions (6% versus 32%; P <.0001), and shorter lengths of stay (2.0 +/- 0.1 days versus 9.8 +/- 1.4 days; P <.0001). Early major adverse events were markedly reduced in the test group (14% versus 57%; P <.0001), and this difference persisted at 2 years. No difference was seen in survival rate (P =.13). In the first 2 years, no deployment failure, early conversion, or aneurysm rupture occurred. At the 2-year timepoint, core laboratory read trunk migration in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. One wire discontinuity (0.6%) was identified in a discharge film. A 7% annual reintervention rate was seen in the test group in the first 2 years. SUMMARY: The test device is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysm. The most striking benefits are reduced blood loss, fewer complications, and faster recovery. Two-year survival rate was similar.
RCT Entities:
OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a novel endovascular graft for elective treatment of infrarenal abdominal aortic aneurysm. The device is a modular bifurcated system with nitinol/expanded polytetrafluoroethylene components and a smaller profile than currently approved devices. METHODS: In a multicenter, concurrent controlled phase II trial, 334 patients underwent treatment with the Excluder bifurcated endoprosthesis (test, n = 235; W. L. Gore & Associates, Inc, Sunnyvale, Calif) or with standard open repair (control, n = 99). Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 2 years were analyzed with univariable and multivariable statistics. RESULTS:Patients in the test group had less blood loss (310 +/- 19 mL versus 1590 +/- 124 mL; P <.0001), fewer homologous transfusions (6% versus 32%; P <.0001), and shorter lengths of stay (2.0 +/- 0.1 days versus 9.8 +/- 1.4 days; P <.0001). Early major adverse events were markedly reduced in the test group (14% versus 57%; P <.0001), and this difference persisted at 2 years. No difference was seen in survival rate (P =.13). In the first 2 years, no deployment failure, early conversion, or aneurysm rupture occurred. At the 2-year timepoint, core laboratory read trunk migration in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. One wire discontinuity (0.6%) was identified in a discharge film. A 7% annual reintervention rate was seen in the test group in the first 2 years. SUMMARY: The test device is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysm. The most striking benefits are reduced blood loss, fewer complications, and faster recovery. Two-year survival rate was similar.
Authors: Venkatesh K Raman; Parag V Karmarkar; Michael A Guttman; Alexander J Dick; Dana C Peters; Cengizhan Ozturk; Breno S S Pessanha; Richard B Thompson; Amish N Raval; Ranil DeSilva; Ronnier J Aviles; Ergin Atalar; Elliot R McVeigh; Robert J Lederman Journal: J Am Coll Cardiol Date: 2005-06-21 Impact factor: 24.094
Authors: C Alberto Figueroa; Charles A Taylor; Victoria Yeh; Allen J Chiou; Madhu L Gorrepati; Christopher K Zarins Journal: J Vasc Surg Date: 2010-06 Impact factor: 4.268
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